TY  - JOUR
AU  - Heitmann, Jonas S
AU  - Schlenk, Richard F
AU  - Dörfel, Daniela
AU  - Kayser, Sabine
AU  - Döhner, Konstanze
AU  - Heuser, Michael
AU  - Thol, Felicitas
AU  - Kapp-Schwoerer, Silke
AU  - Labrenz, Jannik
AU  - Edelmann, Dominic
AU  - Märklin, Melanie
AU  - Vogel, Wichard
AU  - Bethge, Wolfgang
AU  - Walz, Juliane S
AU  - Große-Hovest, Ludger
AU  - Steiner, Martin
AU  - Jung, Gundram
AU  - Salih, Helmut R
TI  - Phase I study evaluating the Fc-optimized FLT3 antibody FLYSYN in AML patients with measurable residual disease.
JO  - Journal of hematology & oncology
VL  - 16
IS  - 1
SN  - 1756-8722
CY  - London
PB  - Biomed Central
M1  - DKFZ-2023-01666
SP  - 96
PY  - 2023
AB  - About half of AML patients achieving complete remission (CR) display measurable residual disease (MRD) and eventually relapse. FLYSYN is an Fc-optimized antibody for eradication of MRD directed to FLT3/CD135, which is abundantly expressed on AML cells.This first-in-human, open-label, single-arm, multicenter trial included AML patients in CR with persisting or increasing MRD and evaluated safety/tolerability, pharmacokinetics and preliminary efficacy of FLYSYN at different dose levels administered intravenously (cohort 1-5: single dose of 0.5 mg/m2, 1.5 mg/m2, 5 mg/m2, 15 mg/m2, 45 mg/m2; cohort 6: 15 mg/m2 on day 1, 15 and 29). Three patients were treated per cohort except for cohorts 4 and 6, which were expanded to nine and ten patients, respectively. Primary objective was safety, and secondary efficacy objective was ≥ 1 log MRD reduction or negativity in bone marrow.Overall, 31 patients were treated, of whom seven patients (22.6
KW  - AML (Other)
KW  - FLT3 (Other)
KW  - Fc-optimized antibody (Other)
KW  - Immunotherapy (Other)
KW  - MRD (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:37587502
DO  - DOI:10.1186/s13045-023-01490-w
UR  - https://inrepo02.dkfz.de/record/278585
ER  -